Evidence map›Paper›PMID 27397061›Full record

Trial reportJournal of atherosclerosis and thrombosis2017

Efficacy and Safety of Long-term Coadministration of Fenofibrate and Ezetimibe in Patients with Combined Hyperlipidemia: Results of the EFECTL Study.

Shinichi Oikawa, Shizuya Yamashita, Noriaki Nakaya, Jun Sasaki, Suminori Kono, Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid (EFECTL) Study Investigators

Open access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Ezetimibe for the prevention of cardiovascular disease and all-cause mortality events.The Cochrane database of systematic reviews · 2018 · on this map
    Pooled it
  3. A Comprehensive, Updated Review of Ezetimibe: Evidence-Based Clinical Use for Atherosclerotic Cardiovascular Disease.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2026
    Review
  4. Article
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Article
  11. Hypertriglyceridemia-Related Pancreatitis In Patients With Type 2 Diabetes: Links And Risks.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019
    Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 1 country.

Shinichi OikawaDepartment of Endocrinology, Diabetes and Metabolism, Graduate School of Medicine, Nippon Medical School.
Shizuya Yamashita
Noriaki Nakaya
Jun Sasaki
Suminori Kono
Effect of Fenofibrate and Ezetimibe Combination Treatment on Lipid (EFECTL) Study Investigators
Fukujuji Hospital · JPInternational University of Health and Welfare · JPNational Institute of Biomedical Innovation, Health and Nutrition · JPOsaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimWe investigated the safety and efficacy of a long-term combination therapy with fenofibrate and ezetimibe in Japanese patients with combined hyperlipidemia, in comparison with fenofibrate or ezetimibe alone.

methodsThe study was a three-arm parallel-group, open-label randomized trial. Eligible patients were assigned to a combination therapy with fenofibrate (200 mg/day in capsule form or 160 mg/day in tablet form) and ezetimibe (10 mg/day), the fenofibrate monotherapy, or the ezetimibe monotherapy, which lasted for 52 weeks. The changes in serum low-density lipoprotein (LDL) cholesterol and triglycerides were the primary outcomes.

resultsA total of 236 patients were assigned to one of the three treatments, and the number of patients included in the final analysis was 107 in the combination therapy, 52 in the fenofibrate monotherapy, and 51 in the ezetimibe monotherapy. Mean±SD changes in LDL cholesterol were -24.2%±14.7% with combination therapy, -16.0%±16.0% with fenofibrate alone, and -17.4%± 10.1% with ezetimibe alone. The combination therapy resulted in a significantly greater reduction in LDL cholesterol as compared with each monotherapy (p<0.01 for each). The corresponding values for triglycerides were -40.0%±29.5%, -40.1%±28.7%, and -3.4%±32.6%, respectively. Fenofibrate use was associated with some changes in laboratory measurements, but there was no differential adverse effect between the combination therapy and fenofibrate monotherapy.

conclusionThe combination therapy with fenofibrate and ezetimibe substantially reduces concentrations of LDL cholesterol and triglycerides and is safe in a long-term treatment in Japanese patients with combined hyperlipidemia.

Indexed as

AdultAgedAnticholesteremic AgentsBiomarkersCholesterolCholesterol, LDLDrug Therapy, CombinationEzetimibeFemaleFenofibrateHumansHyperlipidemiasHypolipidemic AgentsMaleMiddle AgedTreatment OutcomeAnticholesteremic AgentsBiomarkersCholesterolCholesterol, LDLEzetimibeFenofibrateHypolipidemic Agents

Identifiers

PMID27397061
PMCPMC5225135
OpenAlexW2469346154

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.